Gradual vs. Abrupt Cessation Treatment for Smoking

• ClinicalTrials.gov Identifier: NCT00297492
• Recruitment Status: Completed
• First Posted: February 28, 2006
• Results First Posted: September 5, 2012
• Last Update Posted: September 20, 2013
• Sponsor: University of Vermont
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): John Hughes, University of Vermont

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Smoking Cessation
• Interventions: Behavioral: Reduction Phone Counseling; Behavioral: Abrupt Phone Counseling; Behavioral: Minimal Abrupt Phone Counseling; Drug: Pre-Quit Nicotine Lozenges; Drug: Post-Quit Nicotine Lozenges
• Enrollment: 750

Participant Flow

Recruitment Details	Participants were recruited using advertisements targeting smokers who wanted to quit smoking gradually. Advertisements were placed in newspapers in two cities in South Carolina and one city in New Mexico.
Pre-assignment Details	Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment.

Arm/Group Title	Gradual Reduction	Abrupt Cessation	Minimal Intervention
Arm/Group Description	Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date	Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date	Minimal intervention to mimic intervention at a primary care office
Period Title: Set Quit Date
Started	297	299	150
Completed	290	286	145
Not Completed	7	13	5
Reason Not Completed
Lost to Follow-up	7	13	5
Period Title: 6 Month Follow-up
Started	290	286	145
Completed	227	237	118
Not Completed	63	49	27
Reason Not Completed
Lost to Follow-up	63	49	27

Baseline Characteristics

Arm/Group Title		Gradual Reduction	Abrupt Cessation	Minimal Intervention	Total
Arm/Group Description		Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date	Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date	Minimal intervention to mimic intervention at a primary care office	Total of all reporting groups
Overall Number of Baseline Participants		297	299	150	746
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	297 participants	299 participants	150 participants	746 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	273 91.9%	276 92.3%	139 92.7%	688 92.2%
	>=65 years	24 8.1%	23 7.7%	11 7.3%	58 7.8%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	297 participants	299 participants	150 participants	746 participants
		48 (13)	48 (12)	47 (13)	48 (13)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	297 participants	299 participants	150 participants	746 participants
	Female	159 53.5%	165 55.2%	80 53.3%	404 54.2%
	Male	138 46.5%	134 44.8%	70 46.7%	342 45.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	297 participants	299 participants	150 participants	746 participants
		297	299	150	746

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement
Description	Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

This was an intent-to-treat analysis. Those who were lost to follow-up were assumed to not be abstinent from smoking at the time of the 6 month follow-up.

Arm/Group Title	Gradual Reduction	Abrupt Cessation	Minimal Intervention
Arm/Group Description:	Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date; nicotine lozenges were provided to aid reduction prior to the quit date and for use on and following the quit date.	Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date.	Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date.
Overall Number of Participants Analyzed	297	299	150
Measure Type: Number; Unit of Measure: participants
	12	20	7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gradual Reduction, Abrupt Cessation, Minimal Intervention
	Comments	Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.30
	Comments	Statistical significance was determined by a two-sided p value less than 0.05.
	Method	Chi-squared
	Comments	Degrees of freedom = 2

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gradual Reduction, Abrupt Cessation
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95%; 0.28 to 1.22
	Estimation Comments	The reported odds ratio represents the odds of 6 month prolonged abstinence in the gradual reduction group divided by the odds of 6 month prolonged abstinence in the abrupt cessation group.

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Gradual Reduction	Abrupt Cessation	Minimal Intervention
Arm/Group Description	Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date	Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date	Minimal intervention to mimic intervention at a primary care office
All-Cause Mortality
	Gradual Reduction	Abrupt Cessation	Minimal Intervention
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Gradual Reduction	Abrupt Cessation	Minimal Intervention
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/297 (0.00%)	0/299 (0.00%)	0/150 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Gradual Reduction	Abrupt Cessation	Minimal Intervention
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/297 (0.00%)	0/299 (0.00%)	0/150 (0.00%)

Limitations and Caveats

Our projected incidence of abstinence was higher than what was actually observed, leading to lower statistical power than expected.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. John Hughes
• Organization: University of Vermont
• Phone: 802-656-9610
• EMail: John.Hughes@uvm.edu

Publications of Results:

Hughes JR, Solomon LJ, Livingston AE, Callas PW, Peters EN. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Drug Alcohol Depend. 2010 Sep 1;111(1-2):105-13. doi: 10.1016/j.drugalcdep.2010.04.007. Epub 2010 May 26.

• Responsible Party: John Hughes, University of Vermont
• ClinicalTrials.gov Identifier: NCT00297492
• Other Study ID Numbers: R01DA011557-07 ( U.S. NIH Grant/Contract ); R01DA011557-07 ( U.S. NIH Grant/Contract )
• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Results First Submitted: May 31, 2012
• Results First Posted: September 5, 2012
• Last Update Posted: September 20, 2013